BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA HP UNI TIB TRAY SZ2 RMLL

    MDR report key: 1033936 · Received April 24, 2008

    Report

    Report Number
    1818910-2008-01162
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K070267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    INCORRECT SIZE OF IMPLANT IN BOX, EXTENDED THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA HP UNI TIB TRAY SZ2 RMLL 87HRY HRY DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA B55BK4000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other